drugset / Trial / NCT02769689
Methylprednisolone During the Switch Between Natalizumab and Fingolimod
RandomizedParallel-groupDouble-blindTreatment
Summary
Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT. The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).
Timeline
- Start
- 2019-06-12
- Primary completion
- 2024-06-20
- Completion
- 2024-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 1 g | Oral |
| Background | Fingolimod | Small molecule | — | — |
| Background | natalizumab | Monoclonal antibody | — | — |